Quality Auditor, Framingham, MA

Position Overview

Provide QA support to ensure that Upstream, Downstream, Buffer & Media and Clinical Injectable Manufacturing operations supporting pre-clinical and clinical programs are compliant with Regulatory and Global Quality policies and standards.  Provide quality support on Day-to-day operation projects, including deviations, Change Control process, Batch record Review. As a member of the Quality Operations team, you will support strategic direction for all quality and compliance processes.

Core Responsibilities

• Quality oversight of Upstream Cell Culture and Downstream Purification and Clinical Injectable filling operations for mammalian and integrated continuous bioprocessing (iCB) platforms including on the floor QA support

• Quality review of Validation activities, operational SOPs, Deviations and Change Controls

• Ensures compliance with Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring

• Perform contamination control walk through of clean rooms and utility systems; provide recommendations and track actions

• QA review of associated production records.

• QA release of raw materials and buffer /media solutions for use in GMP manufacturing

• Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving Drug Substance operations

• Collaborate with global counterparts to ensure alignment of methodologies and best practices. Communicates and partners with site functions to ensure processes are aligned to program requirements and identify improvement opportunities.

• Perform inspections of manufacturing areas and audits of raw material vendors/CMO’s as required.

Basic Requirements and Experience

• Bachelor’s Degree required, preferably in Biology, Biotechnology or related field

• Minimum 1-3 years of experience in cGMP manufacturing environment required in Pharmaceutical, Biotech or Medical Device.

• Preferred Minimum 1 year of experience in Quality/Compliance.

• Familiarity with regulatory requirements, experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA).

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG
#LI-GZ

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Salary : $120,000 - $0